BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rapr-Round

    DI: 07613327175134 · Model: 8001-061-560 · STRYKER CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rapr-Round
    Primary DI
    07613327175134
    Version / Model
    8001-061-560
    Catalog Number
    8001-061-560
    Company Name
    STRYKER CORPORATION
    Labeler DUNS
    078470558
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    66ed6c1c-d621-4241-a005-6d9298a48848

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DWJ System, thermal regulating

    GMDN Terms

    Code Name
    36854 External circulating-fluid core temperature regulation system pad, reusable

    Identifiers

    Type ID
    Package 57613327175139
    Primary 07613327175134

    Premarket Submissions

    Submission Number Supplement Number
    K100585 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 140 Degrees Fahrenheit